Status:
COMPLETED
The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
COVID-19
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) i...
Eligibility Criteria
Inclusion
- Key
- Over 19 years of age
- COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment
- Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening
- Patients whose body temperature is measured according to the measured area without taking a fever reducer during screening:
- \[armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with rectum greater than 37.6 °C or eardrum greater than 37.5 °C\] (Notes: Although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.)
- Patients with evidence of lung invasions as a result of radiation tests
Exclusion
- Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation).
- Patients who participated in other clinical trials related to COVID-19.
- Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study.
- Patients whose AST or ALT has increased by more than 5 times the normal lab value.
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04347915
Start Date
May 26 2020
End Date
February 26 2021
Last Update
July 22 2022
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea